SMV SCIENTIFIC LLC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sacroiliac Joint Fixation (OUR) (10)

Premarket Exempt

No Yes

Clear

6.5 x 40mm Biomechanical Screw - 00810097800182 Catalog Number : 1252-0006-040

Device Description : 6.5 x 40mm Biomechanical Screw

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

6.5 x 45mm Biomechanical Screw - 00810097800199 Catalog Number : 1252-0006-045

Device Description : 6.5 x 45mm Biomechanical Screw

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

6.5 x 50mm Biomechanical Screw - 00810097800205 Catalog Number : 1252-0006-050

Device Description : 6.5 x 50mm Biomechanical Screw

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

6.5 x 55mm Biomechanical Screw - 00810097800212 Catalog Number : 1252-0006-055

Device Description : 6.5 x 55mm Biomechanical Screw

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

BladeX Cutter - 00810097800229 Catalog Number : 1252-5500

Device Description : BladeX Cutter

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Central Shaft - 00810097800236 Catalog Number : 1252-5510

Device Description : Central Shaft

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Blade, 38mm - 00810097800243 Catalog Number : 1252-5520-238

Device Description : Blade, 38mm

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

2.0mm K-wire - 00810097800250 Catalog Number : 1252-4100

Device Description : 2.0mm K-wire

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

3.2mm K-wire - Long - 00810097800267 Catalog Number : 1252-4102-001

Device Description : 3.2mm K-wire - Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

3.2mm K-wire - Short - 00810097800274 Catalog Number : 1252-4102-002

Device Description : 3.2mm K-wire - Short

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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